MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 977c165, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 26-jun-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient (pt) regarding an implantable neurostimulator (ins).During the call, the pt reported that the ins was replaced because the lead wires were "worn out".Pt just stated that its "been months" since the event.Pt noted that they initially were not sure if the ins was replaced when the healthcare provider (hcp) fixed the leads, so reviewed drs information. no symptoms/patient complications reported.
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Event Description
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Patient reported that no changes on their end.Patient asked to refer to a report.Patient added that patient sent rep a text on (b)(6)2021.The unit is not working and not worked since july '21.Patient thinks the rep could help if he can find time to check the unit.Patient will cooperate with rep on and appointment.
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Manufacturer Narrative
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Continuation of d10: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: (b)(6) 2020 product type lead medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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